Pharmacovigilance: An emerging field to study adverse impact of medicines – Times of India


Pharmacovigilance (Pv) emerged to prominence after the occurrence of many major adverse drug reaction (ADR) disasters including thalidomide tragedy in Germany in the early 1960s. Regulatory agencies in line with industry have formulated strategies to deal with ADRs globally.

What is Pharmacovigilance?

It deals with drug safety and is defined as the study and prevention of adverse effects caused by pharmaceutical products. In response to the thalidomide disaster, WHO established the International Drug Monitoring Programme. More than 134 countries have joined and supported the WHO PV Programme. “The governments across the world support and help implement Pharmacovigilance courses as their primary goal is to ensure that the students of medicine are aware of the adverse effects of certain pharmaceuticals,” says Madhu Chitkara, pro chancellor, Chitkara University, Punjab.

Increasing relevance

With the rise in lifestyle diseases globally, medicine consumption has increased along with increased adverse drug reactions (ADR) and drug toxicity. In addition to a sudden surge in the stringent country-wise compliance practices globally, the current global pandemic has also boosted drug development and pharmacovigilance practices worldwide. Pharmacovigilance aims to enhance patient care and safety concerning the use of medicines; and support public health programmes by providing reliable, balanced information for the practical assessment of risk-benefit profile of pharma drugs.

Course content

The postgraduate course in Pharmacovigilance normally touches upon subjects such as hands-on training on ICSR processing, quality management, aggregate report writing, and compliance management.

“The prime focus is on boosting the expertise in the evaluation of medicines. The programme aims at providing intensive technical exposure in regards to Clinical Research and Drug Safety prospective, with specialisations in ICSR Processing / Quality Management / Medical Safety Writing and Compliance Management,” she says.

Since Pharmacovigilance is an ever-emerging field, the trend and need for industry-driven courses are on the rise. The program includes a six-month immersive internship with clinical research organisations(CRO’s).

The industry-led programme offers specialisations including Advanced ICSR processing, PV Quality Management, PV Medical Safety writing and PV Compliance Management.

Eligibility criteria

Students who have scored a minimum of 50% with graduation in science including medical and non-medical, Medicine, Nursing, Biotechnology are eligible for admission to MSc programme in Pharmacovigilance and Clinical Research programme at Chitkara University.

Career prospects

The Pharmacovigilance Industry is anticipated to grow at a CAGR of 10.6% till 2025 and become an $ 8.9 billion industry globally. Tanveer Naved, head, Pharmacy Department, Amity University, says that demand for those having expertise in Pharmacovigilance will grow in times to come.





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